Omnitrope 15mg/1.5ml (45IU)
Indications of use
Growth retardation linked to a somatotropic deficit
Growth retardation related to Turner syndrome
Growth retardation related to chronic renal failure
Growth retardation in the child born small for gestational age
Somatotropic deficit in adults
Infants, children and adolescents
– Growth retardation due to insufficient secretion of growth hormone (somatotropic deficit).
– Growth delay due to Turner syndrome
– Growth retardation related to chronic renal failure.
– Growth retardation (current size <- 2.5 SDS (standard deviation score) and adjusted parental size <- 1 SDS) in children / adolescents born small for gestational age with birth weight and / or birth size <- 2 standard deviations (SD), not catching up (growth rate (SD) <0 SDS in the last year) at age 4 or older.
– Prader-Willi syndrome (SPW), to improve growth and body composition. The diagnosis of SPW must be confirmed by the appropriate genetic test.
– Substitution treatment in adults with severe somatotropic deficiency.
Deficiency acquired in adulthood: Patients with severe somatotropic deficiency associated with multiple hormonal deficits resulting from a known hypothalamic or pituitary pathology and presenting at least one other pituitary hormone deficiency, except for prolactin. An appropriate dynamic test will be performed to diagnose or rule out growth hormone deficiency in these patients.
– Deficiency acquired in childhood: Patients who developed a somatotropic deficit during childhood of congenital, genetic, acquired or idiopathic origin. In patients with somatotropic deficiency acquired in childhood, the secretory capacity of growth hormone should be re-evaluated once their growth has been completed. If there is a high probability of persistent somatotropic deficiency (congenital cause or deficit secondary to hypothalamic-pituitary pathology or injury), IGF-I <-2 standard deviations at least 4 weeks after stopping treatment by growth hormone should be considered as sufficient evidence of severe somatotropic deficiency.
In all other patients, an IGF-I assay and a growth hormone stimulation test will be required.
Against indications: why not take it?
– Hypersensitivity to somatropin or any of the excipients.
– Omnitrope 15mg/1.5ml (45IU) should not be used if there is evidence of tumor activity. Intracranial tumors should be inactive and any antitumor treatment should be terminated before starting growth hormone therapy. Treatment should be discontinued if there is evidence of tumor growth.
– Omnitrope 15mg/1.5ml (45IU) should not be used to improve the growth of children whose epiphyses are welded.
– Patients who are critically ill, who have complications secondary to open heart surgery, abdominal surgery, multiple trauma, acute respiratory failure, or similar conditions should not be treated with growth. For patients receiving substitution therapy, see Warnings and Precautions for Use.
Dosage and method of administration
Diagnosis and treatment with Omnitrope 15mg/1.5ml (45IU) should be performed and monitored by a specialist physician experienced in the diagnosis and management of patients with growth failure.
The dosage and administration schedule should be appropriate for each patient.
Growth retardation due to growth hormone secretion deficiency in pediatric patients
In general, the recommended dosage is 0.025 to 0.035 mg / kg of body weight per day or 0.7 to 1.0 mg / m2 of body surface area per day. Higherndoses were used.
When the somatotropic deficit acquired in childhood persists in adolescence, treatment must be continued in order to achieve complete somatic development (body composition, bone mass, for example). For follow-up, obtaining a normal peak of bone mass defined as a T> -1 score (ie, standardized according to the peak of adult bone mass measured by biphotonic X-rays, taking into account gender and ethnicity) is one of the therapeutic goals during the transition period. For dosage recommendations, see the Adult section below.
Warnings and precautions for use
Omnitrope 15mg/1.5ml (45IU) can induce insulin resistance. In patients with diabetes, adjustment of the insulin dose may be required after initia tion of somatropin therapy. Patients with diabetes, glucose intolerance or any other risk factor for diabetes should be closely monitored during treatment with somatropin.
Growth hormone increases the extrathyroid conversion from T4 to T3, resulting in a decrease in serum T4 concentration and an increase in serum T3 concentration. Although peripheral thyroid hormone levels have remained in the baseline for healthy subjects, hypothyroidism can theoretically develop in subjects with subclinical hypothyroidism. Therefore, thyroid function should be monitored in all patients. In patients with pituitary insufficiency receiving standard replacement therapy, the potential effect of growth hormone therapy on thyroid function should be closely monitored.
In cases of somatotropic deficiency secondary to antitumor treatment, it is recommended to monitor for signs of recurrence of the tumor process.
In patients with endocrine disorders, including those with growth hormone deficiency, epiphysiolysis of the hip may be more common than in the general population. Any patient with claudication during treatment with somatropin should be examined.
Benign intracranial hypertension
In cases of severe or repeated headaches, visual disturbances, nausea and / or vomiting, it is recommended to perform a fundus to detect any papilledema. If this is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, treatment with somatropin should be discontinued. The current state of knowledge does not support the recommendation of continued growth hormone therapy in patients with resolved intracranial hypertension. If treatment with growth hormone is reinstated, careful monitoring of the occurrence of symptoms of intracranial hypertension is necessary.